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United States Patent |
5,100,410
|
Dulebohn
|
March 31, 1992
|
Means and method for facilitating folding of an intraocular lens
Abstract
A system for facilitating folding a soft intraocular lens. A supporting and
positioning structure associated with a base or frame presents the lens so
that forceps tips are automatically positioned near opposite sides of the
lens and maintained in that position. A forming means automatically moves
the forceps tips with respect to the lens to fold the optic portion of the
lens within the tips. The lens is accurately and reliably folded in the
forceps tips to securely grip the lens in a desired position with reduced
risk of damage to the optic portion of the lens.
Inventors:
|
Dulebohn; David H. (Tonka Bay, MN)
|
Assignee:
|
Andrew Tool Co., Inc. (Tonka Bay, MN)
|
Appl. No.:
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647517 |
Filed:
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January 28, 1991 |
Current U.S. Class: |
606/107; 206/5.1; 623/6.12 |
Intern'l Class: |
A61B 017/00 |
Field of Search: |
623/6
606/107
206/5.1,438
|
References Cited
U.S. Patent Documents
450266 | Apr., 1891 | Truax | 294/992.
|
1837277 | Dec., 1931 | Lund | 606/110.
|
4198980 | Apr., 1980 | Clark | 606/107.
|
4303268 | Dec., 1981 | Davidson | 294/992.
|
4325375 | Apr., 1982 | Nevyas | 606/207.
|
4462404 | Jul., 1984 | Schwarz et al. | 606/142.
|
4573998 | Mar., 1986 | Mazzocco | 623/6.
|
4681102 | Jul., 1987 | Bartell | 606/107.
|
4702244 | Oct., 1987 | Mazzocco | 623/6.
|
4759359 | Jul., 1988 | Willis et al. | 606/107.
|
4769034 | Sep., 1988 | Poley | 623/6.
|
4785810 | Nov., 1988 | Baccala et al. | 606/207.
|
4791924 | Dec., 1988 | Kelman | 128/303.
|
4813956 | Mar., 1989 | Gupta | 623/6.
|
4813957 | Mar., 1989 | McDonald | 623/6.
|
4836201 | Jun., 1989 | Patton et al. | 623/6.
|
4844065 | Jul., 1989 | Faulkner | 128/321.
|
Foreign Patent Documents |
WO82/01646 | May., 1982 | WO.
| |
2191439A | Dec., 1987 | GB.
| |
Other References
"Intracameral Lenses Made of Hydrocolloid Acrylates", by Dreifus, Wichterle
and Lim, of II. Eye Clinic, Charles University from Sc. oftamologie 16(2),
454-459 (1960) (translation from Czech).
"Folding and Inserting Silicon Intraocular Lens Implants", by Gerald D.
Faulkner M. D., J Cataract Refract Surf, vol. 13, Nov. 1987, pp. 678-681.
"Pathologic Findings of an Explanted Silicone Intraocular Lens", by Newman,
McIntyre, Apple, Deacon, Popham, and Isenberg; J Cataract Refract Surg,
vol. 12, May 1986, pp. 292-297.
|
Primary Examiner: Shay; Randy C.
Claims
What is claimed:
1. A means for facilitating folding of an intraocular lens, having a lens
optic to prepare the lens for insertion through a small incision in the
eye, comprising: a base means;
translateable supporting means associated with the base means for
supporting at least a portion of the perimeter of a lens optic;
positioning means associated with the supporting means generally for
receiving and positioning opposite tips of a forceps near opposite sides
of the perimeter of the lens optic when the lens optic is supported on the
supporting means;
manually moveable means associated with the base means for translateably
moving the supporting and positioning means towards one another, folding
the lens optic within the forceps tips while simultaneously maintaining
the forceps tips in a desired position to the lens optic as the lens optic
is folded.
2. The means of claim 1 wherein the supporting and positioning means
comprises curved jaws adapted to be adjacent to opposite diametric sides
of the optic, and the manually moveable means comprises extension means
for allowing mechanical force to be transferred to the curved jaws to
converge the forceps tips towards one another to allow the opposite sides
of the lens optic to be folded onto one another and the forceps tips to
grip the lens optic at a desired position.
3. The means of claim 1 wherein the extension means of the manually
moveable means comprises rigid frame members connected to the base, which
is comprised of resilient frame members, so that manual inward pressure on
the resilient frame members of the base causes convergence of the rigid
frame members which in turn causes folding of the lens optic within the
forceps tips.
4. The means of claim 1 wherein the manually moveable means comprises
moveable members within the base means to simultaneously push opposite
sides of the lens towards one another as forceps tips are closing upon one
another to fold the lens optic within the forceps tips.
5. The means of claim 1 further including an intraocular lens optic
received in the supporting means, the optic being a plano-convex member.
6. The means of claim 1 further including an intraocular lens optic
received in the supporting means, the optic being foldable.
7. The means of claim 6 further including an intraocular lens optic
received in the supporting means, the optic being soft.
8. The means of claim 7 further including an intraocular lens optic
received in the supporting means, the optic being made of silicone.
9. The means of claim 7 further including an intraocular lens optic
received in the supporting means, the optic being made of a plastic
material.
10. A means for folding a soft intraocular lens wherein the lens is folded
within forceps tips that are then used to insert the lens into the eye,
comprising: a base means;
opposite jaw means associated with said base means including: first means
to position and hold a lens, and second means to allow insertion of and to
position the forceps tips with respect to a desired position on top of the
lens near opposite diametrical sides of the lens when the lens is
positioned in the first means; and
manually moveable means connected to the jaw means to manually converge the
jaw means to guide the forceps tips with respect to the lens as it is
being folded in the forceps tips by movement of the jaw means toward one
another.
11. The means of claim 10 wherein the manually moveable means are
integrally connected and formed with the base means, and the base means
has at least portions which are resilient to allow manual movement of the
resilient portion of the base means to move the jaw means.
12. The means of claim 10 wherein the first means of the opposite jaw means
comprises a stepped and curved portion which can position and support a
portion of the bottom perimeter of the optic of a lens.
13. The means of claim 10 wherein the second means comprises a raised
member from the first means to provide a landing for the vertical
insertion of forceps tips to an area adapted to be adjacent opposite
diametrical portions of the top of a optic portion of a lens when the lens
is positioned in the first means.
14. The means of claim 10 wherein the first and second means are curved to
conform generally to curvature of an optic portion of the lens.
15. The means of claim 10 wherein the first and second means are flat
surfaces.
16. The means of claim 10 wherein the manually moveable means are
independent arms extending through bore in the base means along an axis,
the arms moving the jaw means when manually moved along an axis.
17. A device for folding a soft intraocular lens within forceps comprising:
a frame means including a closed resilient rail means defining an interior
area, and aligned inwardly extending arms connecting to the rail means;
spaced apart jaw members positioned at the facing ends of the arms
including,
first curved inwardly extending ledges means for supporting opposite bottom
portions of a lens near the perimeter of the lens;
second concentric curved ledge means positioned on top of the first curled
ledge means and extending inwardly but less than the first curved ledge
means for abutting opposite portions of the perimeter of the lens and
providing a landing for placement of forceps tips;
the spacing between jaw members being such that in a first normal position
the diametrical distance between opposite first curved ledge means is less
than the diameter of the lens, the diametrical distance between opposite
second curved ledge means being slightly greater than the diameter of the
lens, and converging movement, of the jaw members urging a less received
between the jaw member to fold upwardly along a center axis which is
generally perpendicular to an axis between jaw members and midway between
jaw members, the converging movement also folding the lens within the
forceps tips.
18. The device of claim 17 wherein the frame means is made of a plastic
material.
19. The device of claim 17 wherein the first and second curved ledge means
have radii of curvature which are generally similar to the radii of
curvature of the optic portion of the lens.
20. A means of folding an optic portion of a soft intraocular lens along a
first axis formed by a diameter of the lens, comprising:
a base means having top, bottom, and opposite side walls;
an opening extending through the top wall to receive a lens within the base
means;
said opposite arms moveable positioned within bores through opposite side
walls of the base means along a second axis;
inner ends of the arms being moveable towards one another within the
opening in the base means; jaw member configured on each inner end of the
arms, the jaw member including a flat and inwardly extending horizontal
surface and an upwardly angled surface form the horizontal surface forming
an acute angle with the horizontal surface;
the horizontal surface being adapted to support opposite bottom portions of
the perimeter of the optic when the arms are in a first position, the
angled surface being adapted to hold the lens in place generally along
said second axis and accurately position the forceps tips with respect to
the lens when the arms are in the first position;
convergence of the jaw members by manual movement of one or more of the
arms causing accurate upward folding of the lens within the forceps tips,
divergence of the jaws allowing removal of the forceps tips gripping the
folded optic.
21. A method of folding an optic portion of a soft intraocular lens along a
fold line coincident with a diameter of the optic, comprising the steps
of:
supporting opposite bottom, perimeter portions of the optic;
bringing jaw structures into abutment with the perimeter of the optic;
moving tips of a forceps within the jaws adjacent to the optic near the
abutment of the jaw structure with the optic to accurately position the
tips prior to folding of the lens; converging the jaw structures to guide
the forceps tips and concurrently fold the optic within the forceps tips
so that the optic is gripped thereby;
diverging the jaw structures to enable removal of the forceps tips while
the tips are gripping the folded optic.
Description
BACKGROUND OF THE INVENTION
The replacement of lens of a human eye generally utilizes a surgical
procedure whereby an artificial replacement lens is inserted through an
incision in the eye. Once inside the eye, the surgeon manipulates the lens
into a position where it is then secured. To minimize trauma to the eye,
it is most beneficial to minimize the size of the incision through which
the lens is inserted.
This type of artificial lens, generally referred to as an intraocular lens,
is usually comprised of a circular convex or plano-convex optic portion,
with arms called haptics extending from the optic. The haptics are
utilized to hold the lens in place.
A practical limitation on how small the incision in the eye can be is the
diameter of the optic portion of the lens. Although tissue is somewhat
pliable, a slit or incision has to be approximately, at a minimum, the
length of the diameter of the lens. One way to avoid this limitation is to
manipulate the lens to reduce its cross-sectional diameter before
insertion into the eye. An example would be to fold the lens over onto
itself. This would reduce the required length of the incision by
approximately one half.
The present invention relates to lens insertion and intraocular lens
replacement surgery, and in particular, to an improved means and method
for folding a lens in preparing it for insertion into the eye. The
benefits of one smaller incision are less trauma to the eye.
The concept of folding or rolling a lens prior to insertion is known in the
art. See, for example, the following U.S. Pat.:
______________________________________
Faulkner 4,844,065
Poley 4,769,034
Patton 4,836,201
Mazzocco 4,702,244
Bartell 4,681,102
Willis 4,759,359
Baccala 4,785,810
______________________________________
Patents such as Faulkner, Poley, Willis, and Baccala illustrate how the
folding of a lens may be done, or disclose and claim instruments used in
association with such folding. Patents such as Patton, Mazzocco and
Bartell disclose rather complex instruments and associated hardware for
rolling or otherwise manipulating the lens into a smaller cross sectional
or diametric-shape.
It has been determined that although the above technology exists in the
art, there is room for improvement as to how a lens can be reliably and
accurately folded. Intraocular lens replacement is a highly technical and
delicate surgery. It deals with replacing a natural part of the eye with
an artificial implant. The value of eyesight is immeasurable. Therefore,
it is critical that all possible steps be taken to insure the best
possible lens replacement and procedures.
Room for improvement exists in the ability of precise, accurate, and
reliable folding of lens, if that procedure is used. A surgeon needs to
have a good grip on a lens for its insertion. The lens cannot be damaged
or scratched. The folding needs to be accomplished quickly and easily. It
is insufficient, or at least problematic, for a surgeon to accomplish such
delicate and minute folding without some standardized procedure or
structure.
Moreover, it is also disadvantageous to utilize complex procedure or
methods. Complexity leads to the risk of malfunction or, at a minimum,
difficulties in learning the process or structure.
Additionally, the technology regarding the artificial intraocular lenses
themselves has advanced. The optic portions of the lenses themselves may
be made of several different materials. Some of these materials have
characteristics which allow them to provide good optical qualities and
durability. Some of the materials, however, are not particularly easy to
fold or manipulate. One problem deals with lenses which are made of
substances like silicone which are resilient and very deformable. This
makes it difficult to maintain a secure grip on the lens when folded as
the lens has a tendency to return to its original position. The second
problem exists in taking great care to avoid any damage to the lens optic.
Any gripping of the lens, especially near the optical center, runs this
risk.
The need therefore exists for a means and method of reliably and accurately
folding a soft intraocular lens, including those lens optics which are
made of a variety of different materials.
It is therefore the principal object of the present invention to provide a
means and method for facilitating folding of a foldable intraocular lens
which overcomes or improves over the problems and deficiencies in the art.
It is a further object of the present invention to provide a means and
method as above described which presents an easy, accurate, and reliable
way to fold intraocular lenses.
A still further object of the invention is to provide a means and method as
above described which greatly reduces the risk of inaccurate folding and
gripping of an intraocular lens.
A still further object of the present invention is to provide a means and
method as above described which reduces the risk of damage to an
intraocular lens which is folded.
A still further object of the present invention is to provide a means and
method as above described which is noncomplex and easy to understand and
adopt.
A still further object of the present invention is to provide a means and
method as above described which is adaptable to a variety of intraocular
lenses.
Another object of the present invention is to provide a means and method as
above described which minimizes handling of the lens.
Another object of the present invention is described which minimizes the
risk of upside down installation of the lens, as it will always be
packaged, presented, and folded within the forceps tip in the correct
position.
Another object of the present invention is to provide a means and method as
above described which is economical and efficient.
These and other object, features, and advantages of the present invention
will become more apparent with references to the accompanying
specification and claims.
SUMMARY OF THE INVENTION
The present invention presents a system whereby the surgeon can confidently
know that lens can be quickly and accurately folded with forceps, with a
minimum risk of damage to the lens. The method involves the steps of
positioning and supporting the lens to be folded so that forceps tips can
easily and quickly be brought into preselected, desired positions near
opposite diametrical sides of the optic portion of the lens. The tips are
automatically located in optimal positions to grip the lens when it is
folded.
Structure surrounding the tips, and assisting in their placement, can then
be moved by manual force to automatically cause the lens to accurately
fold in two, and the forceps tips to be maintained in continuous contact
with the optic portion of the lens as it is folded. As the tips are held
in position, mechanical force is applied to the structure around the tips
to urge the tips towards one another. The lens is supported in such a way
that its center portion raises, and the structure basically ensures that
the lens folds accurately upon itself and the forceps tips reliably grasp
and hold the lens in the folded shape without the use of a second pair of
forceps or a folding mandrel.
The apparatus according to the invention includes a base, a supporting
structure associated with the base for supporting the lens, a positioning
structure to position and maintain the forceps tips with respect to the
lens, and moveable structure to cause, assist and guide the closing of the
forceps tips concurrently with folding of the lens. The lens can basically
be automatically folded in half. The forming structure is basically a vise
which causes accurate positioning of the forceps tips, and then accurate
closing of the tips and folding of the lens in one quick, easy, and
accurate step. Once folded by the folder, the lens is removed by the
forceps. The forceps does not fold the lens. That is accomplished by the
folder.
The invention allows the surgeon to quickly, with only a few steps and with
high assurance, fold the lens for insertion into the eye with reduced risk
of damage to the lens. This is done with a noncomplex but reliable
structure which is also economical and easy to understand and learn.
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 is a perspective view of an embodiment according to the invention
showing certain portions in an exploded fashion, and also illustrating an
embodiment of a forceps which can be used with the invention.
FIG. 2 is a top plan view taken along line 2--2 of FIG. 1.
FIG. 3 is a top plan view taken along line 3--3 of FIG. 1 also illustrating
the elements (except the forceps) assembled and the position of a rubber
band or other means to hold the elements together for shipping, if
desired.
FIG. 4 is an enlarged sectional view taken along line 4--4 of FIG. 3 but
showing the lens in a supported position.
FIG. 5 is an enlarged sectional view and partial cutaway view taken along
line 5--5 of FIG. 1.
FIG. 6A is an enlarged perspective view illustrating the forceps tips of
FIG. 1 gripping a folded intraocular lens.
FIG. 6B is an enlarged perspective view of an alternative embodiment of
forceps tips gripping a folded intraocular lens.
FIG. 7 is a sectional view generally similar to FIG. 4, but showing the
normal position of an intraocular lens mounted on the invention, and the
initial positioning of a forceps tips with respect to the lens. The
shipping block 24 of FIG. 4 is completely removed in this FIG.
FIG. 8 is similar to FIG. 7 but shows how the invention operates to
automatically begin reliable and accurate folding of the lens in the
forceps tips.
FIG. 9 is similar to FIG. 8 but shows completion of the automatic folding
process of the lens in the forceps tips in the invention.
FIG. 10 is similar to FIG. 9 but shows how the lens, folded and gripped by
the forceps tips, can be separated from the invention.
FIG. 11 is a perspective view of a second embodiment according to the
present invention, showing in somewhat exploded fashion an intraocular
lens and a forceps that can be used with the invention.
FIG. 12 is an enlarged perspective view and partial cutaway view of the
invention shown in FIG. 11.
FIG. 13 is an enlarged sectional view taken along lines 13--13 of FIG. 12
additionally showing the intraocular lens positioned in the invention and
the forceps tips in position prior to the beginning of the folding of the
lens.
FIG. 14 is similar to FIG. 13 but shows the process of beginning the
automatic folding of the lens within the forceps tips.
FIG. 15 is similar to FIG. 14 but showing the completion of folding of the
lens within the forceps tips.
FIG. 16 is similar to FIG. 15 but showing the removal of the folded lens
gripped within the forceps tips from the invention.
FIG. 17 is a top plan view taken generally along line 17--17 of FIG. 11.
FIG. 18 is a top plan view of a third embodiment according to the present
invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
In order to assist in a better understanding of the invention, a detailed
description of preferred embodiments of the same will now be set forth.
The description will be made with reference to the accompanying drawings.
Reference numbers are utilized in the description and drawings to specify
particular parts or locations in the drawings. The same reference numbers
will be utilized for the same parts in all the drawings unless otherwise
indicated.
Turning to the embodiment shown in FIGS. 1-10, folder 10 includes a frame
12. In turn, frame 12 includes a gripping portion 14 and a supporting
portion 16. As can be seen from FIG. 1, frame 12 consists basically of two
mirror images along a longitudinal axis. When discussing gripping portion
14 and supporting portion 16, both opposite mirror image sides of each
portion are included. It is to be understood that folder 10 not only
facilitates the easy and reliable folding of an intraocular lens 18 within
the tips 20 of a forceps 22, but also can serve as a storage device for
the lens prior to insertion. Still further, it can serve as basically a
packaging device whereby the lens 18 can be mounted, secured, and then
packaged in mass quantities for shipping to desired locations. As is well
within the skill and understanding of those within the art, the entire
frame 12, including a lens and a block insert 24, could be secured in
place by a rubber band or the like on the supporting portion 16 of frame
12 (see FIG. 3), and then hygienically packaged within plastic packaging,
or a box for shipment. This eliminates the step of removing the lens 18
from its container, placing it onto folder 10, and then performing the
folding function. Obviously, however, folder 10 could be used in this
manner if desired.
FIG. 2 illustrates how the lens 18 can be placed on curved support jaws 28
and 30 at the supporting portion 16 of frame 12. In its normal position,
the separation between the bottom lens supporting portions of jaws 28 and
30 is slightly less than the outside diameter of the optic portion of lens
18. The separation between the portions of jaws 28 and 30 hold the lens in
position on opposite sides of the perimeter of the lens which is slightly
greater than the diameter of the lens. (See FIG. 4). Note how the
curvature of jaws 28 and 30 basically follows the curvature of the
diameter of lens 18 (see FIG. 2). As will be described in more detail
later, a portion of jaws 28 and 30, however, supports lens 18 underneath
its perimeter, whereas another curved portion of jaws 28 and 30 abuts the
perimeter or a portion of the perimeter of lens 18. This allows lens 18 to
be held in position within jaws 28 and 30. The jaws 28 and 30 of
supporting portion 16 basically cradle and support lens 18. It should be
noted that it is supported only as to portions at or near the perimeter of
lens 18. This reduces the risk of any damage to the center portion of lens
18. FIG. 2 also illustrates how the haptic portions 34 and 36 of lens 18
can be accommodated by the structure of frame 12. The sides of jaws 28 and
30 have cut-out areas 50 and 52 that allow haptics 34 and 36 to enter
unobstructed (as shown in FIG. 2 and 4). These areas 50 and 52 are cleared
to allow space for the haptics when optic 32 is in position as shown in
FIG. 4. This structure is also beneficial to the extent it helps hold the
optic in position. Notice also how the stops 38 and 40 on the gripping
portion 14 of frame 12 are somewhat separated. The stops 38 and 40
determine how far the opposite sides of gripping portion 14 can move
towards one another when manual pressure is applied inwardly. As will be
further described below, such manual pressure causes jaws 28 and 30 to
move together which controls the folding process of lens 18.
FIG. 3 is similar to FIG. 2 except it shows how block insert 24 and lens 18
can be packaged and secured in supporting portion 16 of frame 12. Lower
legs 42 and 44 of blocking insert 24 matingly insert into a space above
support jaws 28 and 30, abutting vertical walls 54 and 56 of jaws 28 and
30 to prevent jaws 28 and 30 from moving towards one another which could
damage or dislodge lens 18. Note also how block insert 24 includes
circular opening 58 and spacing between legs 42 an 44 to avoid any
potential damage to optic portion 32 of lens 18. Legs 42 and 44 prevent
dislodging of the lens during shipping and handling. The center portion of
optic 32 needs to be clear and free from abutment or abrasion with
anything.
FIG. 4 shows in more detail the exact structure of supporting portion 16 of
frame 12. In particular, it shows how lens 18 sits directly on top of
curved support jaws 28 and 30. Furthermore, raised curved ledges 46 and 48
exist on top of support jaws 28 and 30. These ledges serve as stops when
block insert 24 is inserted, so that block insert 24 does not abut or
damage lens 28. As described above, ledges 46 and 48 also serve to cradle
or above opposite portions of the perimeter of optic portion 32 of lens 18
to hold it in position. Note again how in the conventional normal position
of frame 12, lens 18 is supported in its normal flat condition and
absolutely no structure abuts or is adjacent to the top or bottom center
portion of optic 32 of lens 18.
FIG. 5 shows in more detail the exact structure of the supporting portion
16 of frame 12, in an enlarged fashion. It is noted that there is no
supporting structure immediately beneath the center of lens 18 when
supported. Also, there is no mandrel or other structure beneath lens 18 to
assist folding of lens 18. This reduces risk of damage to lens 18 and
distinguishes the present invention from some other lens folders. A better
view of the curved nature of jaws 28 and 30, and raised ledges 46 and 48
can be seen. Also note that channels 60 and 62 can be utilized to guide
and maintain a rubber band or other means around frame 12 if desired. A
similar channel can exist on insert 24 to cooperate with a rubber band.
Still further, FIG. 5 illustrates how jaws 28 and 30 support the lens in an
intermediate position in frame 12, both from either side of frame 12, and
from the top and bottom of frame 12. This further facilitates the easy and
secure packaging and shipping of frame 12 with a lens 18 in place, and
also makes it easy for the surgeon to use when ready to fold and grasp the
lens during surgery. FIG. 6 illustrates tips 20, similar to those
illustrated in FIG. 1, are unique in that they consist of an oval shaped
frame 64 with an opening 66 in the middle. Teeth 68 extend from the bottom
of oval shaped frame 64 upwardly at spaced apart locations of each tip 20.
As shown in FIG. 6A, when the optic portion 32 of lens 18 is folded,
portions of the folded lens 18 can expand into openings 66. This is
especially true for the type of silicone lenses which tend to creep out
from within the grasp of the forceps. The ability to conform and expand
into opening 66 assists in insuring that the lens 18 can be reliably and
accurately gripped and maintained in the accurately folded position. Still
further, teeth 68, as optional features, can further this goal by
providing assistance in gripping those portions of lens 18 that extend
into opening 66.
FIG. 6A shows how a particular set of tips 20 of forceps 22 can be used to
fold and grip a lens 18.
It is furthermore pointed out that tips 20 shown in FIG. 6A are configured
to allow haptics 34 or 36 to be folded up inside tips 20, either through
or between openings 66, or in other manners well within those ordinary
skill in the art. Tips 20 could also include hooks, appendages, or other
connection means for securing a haptic 34 or 36, if desired. This would
facilitate the control of position of haptic 34 or 36 and prevent them
from effecting the insertion process of lens 18 into the eye.
FIG. 6B illustrates a more generic set of tips 20A for forceps 22A. In this
embodiment tips 20A are merely flat, elongated members which are angled
with respect to the body of forceps 22A. Each tip 20A would be converged
upon opposite sides of the folded lens 18 as can be well appreciated in
the art. It is pointed out that the invention could be used with a variety
of different forceps and forceps tips.
FIGS. 7-10 illustrate the operation of folder 10. Each of these figures
illustrates a particular stage of the process of folding of lens 18. It is
to be understood that the primary advantage of folder 10 is the ability to
support lens 18 in the vice-like structure of jaws 28 and 30, which at the
same time allows virtually automatic positioning of tips 28 of forceps 22
in this vice-like structure. Thereafter, it is only a matter of manually
closing the jaws 28 and 30 of the vice-like structure of folder 10. As
jaws 20 and 30 converge, the portions underneath lens 18, prevents lens 18
from moving downwardly, and the presence of forceps tips 20 on the
perimeter edges of lens 18 causes lens 18 to fold upwardly inside the
pre-positioned forceps tips 20. The process continues until forceps tips
are pushed together to the point where the lens, now accurately and
reliably folded into the tips, can be reliably gripped and removed, ready
for insertion into the eye.
FIG. 7 is similar to FIG. 4, and shows how raised ledges 46 and 48 serve to
automatically position tips 20 of forceps 22 immediately by the perimeter
edge of the optic portion 32 of lens 18. This allows the surgeon to
quickly and easily position the tips so that they will accurately and
reliably grasp and remove the lens. There does not have to be any manual
estimation or checking of positioning of the forceps tips 20.
FIG. 8 then shows that once tips 20 of forceps 22 are positioned, gripping
portion 14 (see FIG. 1) is squeezed together to begin folding of lens 18
in tips 20. The movement of the opposite sides of gripping portion 14 in
turn causes the movement of opposite sides of supporting portion 16 to
cause support jaws 28 and 30 to move towards one another (illustrated by
arrows 70 and 72). This automatically moves forceps tips 20 towards one
another while causing the optic portion of lens 18 to bow and fold
upwardly. It also automatically controls the position that forceps tips 20
will grasp the lens.
FIG. 9 shows the completion of movement of the opposite sides of supporting
portion 16 towards one another and the correct and accurate gripping of
the lens 18 above the perimeter edge of the optic 32. The forceps tips are
then squeezed together prior to releasing pressure applied to portion 14.
Finally, FIG. 10 shows that when the gripping portion 14 is released to
allow the opposite sides to resiliently move apart (back to their normal
position) from one another, the opposite parts of supporting portion 16
also move apart to allow the forceps tips to continue to reliably grip
lens 18 and remove it from folder 10 for insertion into the eye during
surgery.
The embodiment of FIGS. 1-10 can be made of a white polypropylene material.
Optic portion 32 of lens 18 has a diameter of approximately 0.240 inches.
The width of the portion of jaws 28 and 30 upon which lens 18 would be
supported is approximately 0.02 inches.
FIG. 11 shows a second embodiment of the present invention. Folder 100
comprises a base 102 of generally cylindrical shape but having a channel
104 generally bisecting base 102 laterally. A circular bore 106 exists
through the center of base 102 along its vertical axis.
Folder 100 works very similarly to folder 10 previously described with
respect to FIGS. 1-10 except it utilizes moveable arms 108 and 110 each
having beveled or notched inner ends 112 and 114. The beveled inner ends
112 and 114 provide the support and positioning of lens 18 in holder 100.
Arms 108 and 110 are mateably insertable and slideable through square
bores 116 and 118 in base 102. The outer ends of arms 108 and 110 are
always gripable and manually maneuverable by a user to allow the user to
move one or both arms 108 and 110 towards and away from one another. FIG.
11 shows how a lens 18 can be moved and inserted between arms 108 and 110
by either setting it upon horizontal ledges 124 and 126 of beveled ends
112 and 114 from above, or sliding it in through channel 104 sideways onto
ledges 124 and 126. The opening defined by channel 104 and bore 106 then
allows tips 20 of forceps 22 to be inserted downwardly into folder 100 and
automatically positioned as shown in FIG. 13.
FIG. 12 shows in more detail the relationship of arms 108 and 118 and base
102. In a normal position, arms 108 and 110 are separated a sufficient
distance so that a lens 18 in its normal unfolded state can be placed on
ledges 124 and 126. Additionally, arms 108 and 110 are positioned so that
the opposite perimeter edge of lens 18 abuts against the beveled inner
ends 112 and 114 at the junction of upwardly angled portions 120 and 122
with ledges 124 and 126 respectively (see FIG. 13). The bevelled inner
ends 112 and 114 therefore serve the dual purpose of supporting lens 18
and maintaining it in a secure position.
Note also that recesses 128 and 130 can be formed in the extra side wall of
base 102 if desired to make gripping of the outer ends of arms 108 and 110
easier.
Turning to FIGS. 13-16, the sequence of steps for folding of the lens are
shown. These are essentially similar to those shown at FIG. 7-10. In this
case, however, either one arm 108 or 118, or both arms 108 and 118 can be
moveable. As depicted in FIG. 13, set screws 132 and 134 could optionally
be included to be threadably moveable in threaded bores 136 and 138 in the
top of base 102 in alignment of arms 108 and 110. Set screws 132 and 134
could then be adjustable to either secure either arm 108 or 110 into a
fixed position, or loosen to allow slideable, lateral movement. Set screws
132 and 134 are optional, and other types of securing means, either
releaseable or not, could be utilized with the invention. Therefore, it is
to be understood that either arm can be releasably secured in any linear
position by means known in the art such as a set screw or some other
device.
It can be appreciated, the depictions in FIGS. 13-16 (as in FIGS. 7-10)
illustrate forceps tips 22 of the particular type of forceps 20, where the
tips 22 have the shape and configuration shown in more detail in FIG. 6A
(see also FIG. 17). The cross sectional views of FIGS. 13-16 (and 6-10)
show that the tips 22 are bowed or curved along a longitudinal axis.
Therefore, in these figures, only the first portions of tips 22 which are
diverging are seen. As can be more fully appreciated with reference to
FIG. 17, these particular forceps tips 22 from a top view have an inside
concave shape and an outside convex shape. It is to be clearly understood,
however, that alternative types of forceps and forceps tips can be
utilized as has been previously explained.
FIG. 14 illustrates that manual force against one or both of arms 108
and/or 110 inwardly (as indicated by arrows 138 or 140) will in turn move
beveled inner ends 112 and/or 114 towards one another. Similarly to jaws
28 and 30 of folder 10 in FIG. 1, the forceps tips 22 are automatically
positioned and the lens is folded within the tips automatically by this
system. One difference between beveled inner ends 112 and 114 and jaws 28
and 30 is that the beveled inner ends 112 and 114 are not curved to mimic
the perimeter of lens 18. However, as can be appreciated with reference to
FIG. 18, the upward bowing of lens 18 when arms 108 and/or 110 is/are
moved inwardly lifts the bottom surface of lens 118 so that there again is
a reduced risk of any damage, abrasion, or abutment of the middle portion
of optic 32 with the structure of folder 100.
FIG. 15 shows the further step of bringing arms 108 and 110 into further
convergence accurately and automatically folding lens 18 within tips 22.
FIG. 16 shows how arms 108 and 110 can then be retracted and the forceps
can be raised from folder 100 with the accurately folded lens particularly
gripped in tips 22.
FIG. 17 shows the top plan view of folder 100. It further illustrates how
forceps tips 20 are automatically positioned with respect to optic 32 by
the configuration of beveled inner ends of 112 and 114 or arms 108 and 110
when they are in what is called their "normal" position supporting lens 18
in its unfolded stated. Note further how the curved segments of bore 106
allow haptics 34 and 36 to be positioned under supporting arms 108 and 110
in generally normal position when lens 18 is supported in an unfolded
state on folder 100. Note also that the beveled inner ends 112 and 114
only support a relatively small portion near the perimeter of optic 32.
Channel 104 basically steers the forceps 22 into a position perpendicular
to arms 108 and 110. By referring back to FIG. 13-16, it can also be seen
that a space exists underneath inner beveled ends 112 and 114 to
accomodate the haptics without damage during storage and folding.
Folder 100 can be made of a variety of different materials. For example,
base 102 can be made of a variety of different types of plastics, as can
arms 108 and 110. Arms 108 and 110 can alternatively be made of metal or
other materials if desired.
FIG. 18 shows a still different embodiment of the invention. The folder 10A
is quite similar to folder 10. In fact, its supports jaws 28A and 30A are
exactly the same as jaws 28 and 30 of folder 10. Lens 18 is supported and
folded in exactly the same manner because of this identity of structure.
Additionally, a block insert 24A can be used for storage and/or packaging
and/or shipping, as explained with regard to folder 10.
The major difference between folder 10A and folder 10 is the configuration
of frame 12A (except for jaws 28A and 30A). Instead of having an explicit
gripping portion 14 and supporting portion 16, as described with respect
to folder 10, folder 10A basically has an oval shaped outer frame with the
jaws 28A and 30A extending inwardly towards each other at the center of
this frame. The resilient nature of frame 12A would allow the user to
basically push the sides of frame 12A together in line with jaws 28 and 30
on opposite sides to allow the jaws 28A and 30A to move towards each other
once block insert 24A is removed. This embodiment represents a more
simplified version but one which still would adequately protect lens 18
from all sides, when block insert 24A is used and the entire folder 10A is
boxed or packaged for shipment.
It can therefore be seen that the invention achieves at least all of its
stated objectives. It will be appreciated that the present invention can
take many forms in embodiments. The true essence and spirit of this
invention are defined in the appended claims, and it is not intended that
the embodiment of the invention herein should limit the scope thereof.
The invention presents a lens folding device which is economical, from a
variety of standpoints, including but not limited to manufacturing,
packaging, and use. Its economical nature can allow it to be packaged with
individual lenses so that all the surgeon has to do is open the sterilized
package, remove any block inserts or other packaging materials,
automatically have the lens folded within the forceps tips, and throw the
folder away. Alternatively, of course, the folder could be reutilized if
sterilized.
The folder is relatively small in size, has few critical tolerances and
moving parts, if any depending upon the embodiment, and improves the
ability of the surgeon to quickly but accurately and reliably fold and
grasp a foldable intraocular lens. The invention basically operates as an
automatic forceps tips positioner with respect to the lens and then as a
vise which automatically maintains the accurate gripping position of the
forceps tips while the lens is folded within them. It eliminates the
surgeon having to manually estimate the correct gripping location or
having to utilize two forceps or other instruments to assist in the
folding process.
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